Job Title: Executive/Sr. Executive Quality Assurance Key Responsibilities

1. Shop Floor Monitoring & Line Clearance

- Line Clearance: Verify the cleanliness, readiness, and status of areas, equipment, and materials before initiating dispensing, granulation, compression, coating, filling, or packaging batches.
- Real-Time Surveillance: Conduct routine plant rounds to monitor active manufacturing processes, ensuring operators strictly adhere to established SOPs and cGMP standards.

2. In-Process Testing & Sampling

- Perform IPC Checks: Execute or witness in-process quality tests
- Sampling Operations: Collect in-process, finished product, validation, and control samples according to defined sampling protocols.
- Environmental Monitoring: Assist in monitoring cleanroom parameters, including non-viable particle counts, viable monitoring, and compressed air/nitrogen gas checks where required.

3. Documentation & Batch Record Review

- BMR/BPR Review: Review Batch Manufacturing Records (BMR).




- Document Control: Control the issuance, reconciliation, and retrieval of manufacturing logs, labels, and container seals.

4. Deviation & Event Management

- Identify Non-Conformances: Halt operations or intervene immediately on the shop floor if process deviations, equipment malfunctions, or quality risks are detected.
- Investigation Support: Assist QMS and production teams in documenting deviations, performing root-cause analysis (RCA), and implementing effective Corrective and Preventive Actions (CAPA).

5. Audit Readiness & Compliance

- Audit Support: Maintain the shop floor in a continuous state of inspection readiness for internal, client, and regulatory audits (e.g., FDA, MHRA).

Contact - Praveen Kumar

Mail: [email protected]

Mobile: (phone hidden)

📌 Executive & Senior Executive - Quality Assurance (IPQA) (Nellore)
🏢 Aurobindo Pharma
📍 Nellore